AXOGUARD HA+ NERVE PROTECTOR
Received Apr 5, 2026
Report 3017860045-2026-00004 · MDR key 24787122
Device
Generic name
Cuff, Nerve
Manufacturer
Axogen CorporationProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Inflammation
Narrative
Description of Event or Problem
ON AN UNKNOWN DATE 8-9 MONTHS AGO, PATIENT HAD HA+ NERVE PROTECTOR IMPLANTED DURING A CARPAL TUNNEL PROCEDURE. DUE TO INFLAMMATION OBSERVED ON AN UNSPECIFIED DATE, THE SURGEON RETURNED TO THE OPERATING ROOM. UPON SURGICAL EVALUATION, NO PURULENCE WAS OBSERVED. THE SURGEON EXPLANTED THE HA+ NERVE PROTECTOR AND NOTED CONCERN FOR A POSSIBLE FOREIGN BODY REACTION; HOWEVER, NO PATHOLOGY OR CULTURES WERE SENT FOR CONFIRMATION. THE AREA WAS CLEANED, AND NO FURTHER INTERVENTION WAS REQUIRED. FOLLOWING EXPLANT, THE PATIENT'S SYMPTOMS COMPLETELY RESOLVED. NO ADDITIONAL COMPLICATIONS WERE REPORTED. SURGICAL TECHNIQUE, PATIENT COMPLIANCE, AND ADDITIONAL TREATMENT INFORMATION NOT AVAILABLE.